ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32850 results sorted by trial registration date.
  • SIR HELLEN (Spinal Cord InjuRy in the Hunter's Exoskeleton for Lower Limb Exercise and Neurorehabilitation)

    Each year in Australia 300-400 new cases of Spinal Cord Injury (SCI) are reported with prevalence predicted to continue to increase with population growth and improved medical care. The most obvious consequence of SCI is paralysis however it also has an impact on many other body functions as well, including social, financial and psychological implications. Most long-term wheelchair users adopt a sedentary lifestyle with prolonged sitting and limited opportunities to engage in physical activities. As a result, many people with SCI experience progressive physical deconditioning and its associated multifactorial health consequences such as diabetes and hyperlipidaemia. This contributes to loss of functional ability and the increased risk of cardiovascular morbidity and mortality. Physiotherapy during rehabilitation focuses on goals related to improving functional ability such as walking, transferring, propelling a wheelchair, balance and upper limb usage. This involves the management of weakness, reduced range of movement, decreased fitness, pain, and respiratory compromise. For those patients with paralysis there is often great difficulty in assisting them to stand and support their body weight. It places a substantial burden on therapists who must assist the patient into standing whilst trying to facilitate exercise and prevent falls. Therefore, these patients are often denied opportunity for the intense, functional therapy this is required to produce positive outcomes. The development of robotic exoskeletons has the potential to overcome the current limitations to therapy. These overground exoskeletons provide motorised assistance at the hips, knees and ankles via motors and coordinate movements at these joints to produce or assist with standing, upright exercises, and walking. They can be used to make gait training, transfer training, and balance training, easier and provide a safe opportunity for intensive practice related to standing and strenuous exercise. There are many different types of robotic exoskeletons currently available but there is no published evidence investigating the patient benefits of using the REX Bionics exoskeleton (HELLEN) as a rehabilitation tool. We aim to examine the potential benefits of using this device as an adjunct tool for rehabilitation in people with SCI. This data will be compared to data being collected in adjacent trials in Stroke and Multiple Sclerosis, currently being conducted by this research team.

  • Does a peer-supported lifestyle modification program improve health outcomes and satisfaction with care for obese patients.

    Obesity is a major contributing factor in chronic disease burden within our community. While there are already established intervention management strategies for obesity, results on conventional primary care, non-invasive and/or drug-free approaches appear to be inconclusive. The planned study focuses on evaluating the efficacy of an already existing, peer-supported, behavioural change obesity intervention program, the “My Health for Life” (MH4L) program. The MH4L program is based around scheduled peer support sessions facilitated by a trained health or allied health professional. Participants in the intervention group also receive a MH4L workbook and printed material to assist with the behaviour change process. This is all in addition to their usual general practice care for weight management. This group will be compared with an active control where participants receive regular GP led management for obesity (6 month management plan designed by the participant’s regular GP which includes 5 visits to appropriate allied health services and 5 visits to chronic disease nurses as well as regular GP consultations as appropriate). All participants are tracked for 2 years after randomisation with measurements significant to obesity taken every 6 months. The study is a single blinded, randomised controlled trial. This means that there are two different treatment groups. One group is called the control group and they will receive currently established management for obesity. Another group is called the treatment group who will receive the new management program for obesity. Participants are not told what group they are assigned to (single blind) and group assignment is random. There is a 2 in 1 chance of being placed in the new treatment group. It is hoped that all participants in this study will, at a minimum, receive the best and most current medical management for obesity. However, the study will reveal the efficacy of a peer-supported obesity management program.

  • Neural mechanisms of lisdexamfetamine in binge eating disorder.

    While Lisdexamfetamine dimesylate (LDX) is indicated for moderate to severe binge-eating disorder (BED) in Australia, the exact mode of its therapeutic action in BED remains unknown. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that: 1. LDX will act by altering connectivity within and between brain circuits responsible for reward and inhibition. 2. A reduction in binge-eating behaviours will correlate with increased activity and connectivity of brain regions within reward and inhibition circuits.

  • For replacing a single missing tooth with implant, is there a difference between the traditional and the new techniques for placing implants in relation to accuracy and restoration longevity

    The purpose of this study is to compare the ease of use and accuracy of 3 different protocols currently used at the Royal Dental Hospital of Melbourne to place dental implants. Specifically, the study will measure exactness of the placed implant in comparison to the planned implant position. In addition, it will evaluate if the type of implant restoration has an effect on the clinical outcome.

  • Resuscitating newborn infants with the umbilical cord intact- The Baby-Directed Umbilical Cord Cutting (Baby-DUCC) Trial

    Participants: In infants greater than or equal to 32 weeks gestational age at birth who require resuscitation at delivery, Intervention: Does establishing effective ventilation, either via PPV or effective spontaneous breathing, prior to umbilical cord clamping* versus Comparator: Standard care- immediate cord clamping followed by resuscitation Outcome: Result in a higher average heart rate between 60-120 after birth. *In the intervention arm (Baby-DUCC), infants that receive PPV will have umbilical cord clamping at least 1 minute after pedicap/neostat colour change, or at least 2 minutes after delivery, which ever time occurs last. Pedicap/neostat colour change indicates exhaled carbon dioxide levels are greater than or equal to 15mmHg, therefore, the lungs are aerated and pulmonary gas exchange has begun. If the infant is still receiving PPV at 5 minutes, the umbilical cord will be cut and the infant will be moved to the warming bed. If the infant requires respiratory support after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect heart rate and SpO2 data in the first 10 minutes after birth.

  • Development of Recommendations for Speech-Language Pathologists in Paediatric Palliative Care Teams (ReSP3CT)

    Given the scarcity of literature and no clinical practice guidelines written for speech pathologists (SPs) currently working in paediatric palliative care, a need was identified to explore the scope of clinical practice and strategies used by SPs. This study therefore aims to undertake an international investigation of clinical practice by gathering data from comprehensive literature searches, demographic surveys, in­-depth interviews and an online Delphi study, to identify current speech pathology (SP) practices, experiences and opinions with the purpose of developing current consensus-­driven 'Recommendations for Speech­Language Pathologists in Paediatric Palliative Care Teams' (ReSP3CT).

  • An evaluation of the Sleeping Sound program on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.

    ASD is a prevalent neurodevelopmental disorder associated with serious adverse outcomes, which compromises the individual’s life chances and productivity. Up to 80% of children with ASD experience sleep problems, with these sleep problems exacerbating existing impairments. Treating sleep problems in children with ASD is associated with markedly improved functioning, including improvements in the core symptoms of ASD. To date, sleep interventions for ASD are largely based on research conducted in samples of children with ASD who are intellectually able. There is a gap in services available for children with ASD with an intellectual disability. We now plan to extend the Sleeping Sound program for children with ASD who also have an intellectual disability, with the ultimate goal of using this intervention to improve outcomes for the entire autism spectrum. The development of such program will represent a major treatment breakthrough for children with ASD with an intellectual disability. The proposed study will also result in a significant advance in the treatment of sleep problems in children with developmental disabilities. It is hypothesised that the Sleeping Sound program will be acceptable and feasible to parents of children with ASD+ID and that the following benefits will be observed in comparison to a treatment as usual comparison group: 1. Reduced sleep problems 2. Fewer social-communication symptoms, emotional/behavioural disturbance 3. Improved quality of life 4. Improved parent mental health.

  • Amyloid deposition and cognitive function in Obstructive Sleep Apnoea

    Obstructive Sleep Apnoea (OSA) is a highly prevalent chronic illness, characterised by repetitive collapse of the airway during sleep, causing falls in blood oxygen levels and sleep disruption. OSA is associated with cognitive deficits, especially memory impairments. Another common condition, dementia, is in the top 4 causes of burden of disease of high-income nations. It affects over 340,000 Australians. OSA is common in patients with dementia, with estimates of 38-45% of dementia patients having OSA. The risk of Alzheimer’s disease and vascular dementia has been shown to increase in patients with OSA. However, a direct causal link between these two conditions has not been established. Beta-amyloid deposits are commonly found in the brains of patients with dementia, and are implicated in the development of dementia. Positron emission tomography (PET) can be used to assess levels of amyloid in the brains of patients, and these levels can be associated with cognitive function. Previous studies performed at Austin Health have found significant associations between amyloid levels and memory impairment in patients with mild cognitive impairment. To date, no studies have examined whether OSA is associated with higher levels of beta amyloid deposits or Alzheimer’s disease -type neural changes, or how these changes relate to cognitive performance. This study will use PET scanning techniques to examine the levels of amyloid in the brains of patients with OSA, and compare these to brain scans of healthy participants. This study will also conduct cognitive assessments in the OSA patients and healthy controls, examining associations between cognitive performance and amyloid levels. Identifying potential biomarkers of amyloid burden in OSA could have important implications for early detection and risk assessment. Early identification of the risk of developing dementia in patients with OSA is important as it allows the possibility of a simple intervention that targets the sleep disorder that may be contributing towards the development of neural and cognitive impairment, before it progresses to dementia.

  • Bowel Preparation Assessment Using Ultrasound Examination II

    Poor bowel preparation is common in inflammatory bowel disease (IBD) and can lead to incomplete colonoscopic assessments and missed pathology. As such the patients are required to undergo either a second colonoscopy or earlier surveillance colonoscopies. This creates cumulative risks of colonoscopies (double the anesthetic and procedural risks), increased burden to the health care system (extra resources and colonoscopy spots used that could be used by other patients) and the patient (more inconvenience of further bowel prep and missed work for the procedure) as well as financial costs both to the health care system as well as the patient in multiple ways. Being able to assess the patient's bowel preparation before giving them anaesthetic and more importantly, being able to know their prep is poor and given them extra bowel prep and have their procedure delayed by a few hours (put at the end of the endoscopy list) would be of huge benefit for both the patient and the health care system. Our aim is to show that randomisation to the rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to assess bowel preparation quality and allow for intervention (extra bowel prep) if required will be superior to the current standards (no ultrasound assessment) and can avoid the detrimental effects of poor bowel prep.

  • Kindred: A pilot study of moderated online social therapy for carers of youth with borderline personality disorder

    This study is a single group, pre- and post-follow-up pilot trial that aims to evaluate the acceptability and safety of an innovative moderated online social therapy (MOST) intervention called Kindred, designed to support carers of young people who are receiving treatment for borderline personality disorder (BPD) pathology within a specialist early intervention service for youth. Kindred comprises three highly integrated functions within one web-based application. These include: (1) online psychoeducation and interactive therapy (divided into specific thematic pathways which are further separated into individual "steps"); (2) expert moderated social networking (via a "cafe"); and, (3) peer moderation. Acceptability and safety will be assessed by patterns of use of the Kindred intervention along with an interview with carers and a questionnaire, the Post-Study Usability Questionnaire (PSSUQ).

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